GOLDEN YELLOW SCJ 1006

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

23.5 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

75

Modified dose descriptor starting point:

NOAEC

Value:

1 763 mg/m³

Explanation for the modification of the dose descriptor starting point:

No long-term inhalative toxicity data is available for FAT 40543; therefore, anticipating comparable absorption by inhalative and oral route, a NOAEC corr of 1000 mg/kg/day / 0.38 m^3/kg * 6.7/10 = 1763 mg/m^3 is used.

AF for dose response relationship:

1

Justification:

not required as starting point is NOAEC corr.

AF for differences in duration of exposure:

6

Justification:

default value for sub-acute study data

AF for interspecies differences (allometric scaling):

1

Justification:

not required due to route to route extrapolation

AF for other interspecies differences:

2.5

Justification:

default factor for remaining differences

AF for intraspecies differences:

5

Justification:

or worker, a default AF of 5 is to be used

AF for the quality of the whole database:

1

Justification:

not required, available data fulfill scientific principles

AF for remaining uncertainties:

1

Justification:

not required, no other uncertainties need to be considered

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

3.33 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

300

Modified dose descriptor starting point:

NOAEL

Value:

1 000 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

oral to dermal, equivalent absorption assumed and therefore no correction applied

AF for dose response relationship:

1

Justification:

NOAEL was used as the starting point

AF for differences in duration of exposure:

6

Justification:

based on a sub-scute study result

AF for interspecies differences (allometric scaling):

4

Justification:

rats were used in tests

AF for other interspecies differences:

2.5

Justification:

no other substance-specific data was available

AF for intraspecies differences:

5

Justification:

default factor for workers

AF for the quality of the whole database:

1

Justification:

not required, available data fulfill scientific principles

AF for remaining uncertainties:

1

Justification:

not required, no other uncertainties need to be considered

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - workers

There is no available toxicity data concerning the test substance on humans.

In a sub-acute toxicity study, the test substance was administered daily by oral gavage to Wistar rats of both sexes at dose levels of 0, 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. No adverse treatment-related effects were noted on any parameter observed during the study. 1000 mg/kg body weight/day of the test item was established as the no-observed-adverse-effect-level (NOAEL).

Another available report was conducted according to OECD guideline 421 under GLP condition. FAT 40863 A/TE was administered by daily oral gavage to male and female Wistar rats at dose levels of 100, 300 and 1000 mg/kg, also showing no treatment related effects and establishing to NOEL in this study at 1000 mg/kg bw/d too for parental toxicity and reproductive toxicity being in a good agreement with the results from the 28-day repeated dose toxicity study (see above).

Studies on acute oral and acute dermal toxicity at dosing up to 2000 mg/kg bw showed no treatment related effects and neither were effects seen on skin and eye irritation in in vivo studies. In a LLNA study for skin sensitisation (OECD 429), very slight skin sensitising effects were seen but were not considered relevant for classification. Thus, the substance is not considered a skin sensitiser. Although an Ames test was positive and also an in vitro chromosome aberration test, the negative in vivo test result is considered more reliable for its higher similarity to the human metabolic environment. In addition, the in vitro gene mutation test in Chinese hamster cells (V79) was negative as well. Thus, we can conclude that the test substance indicates no genetic toxicity under the experimental condition.

The toxicological data above were taken into account for DNEL derivation as described.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

5.8 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

150

Modified dose descriptor starting point:

NOAEC

Value:

870 mg/m³

Explanation for the modification of the dose descriptor starting point:

No long-term inhalative toxicity data is available for FAT40543; therefore, anticipating comparable absorption by inhalative and oral route, a NOAEC corr of 1000 mg/kg/day / 1.15 m^3/kg = 870 mg/m^3 is used.

AF for dose response relationship:

1

Justification:

NOAEC is used as the starting point

AF for differences in duration of exposure:

6

Justification:

based on the sub-acute study

AF for interspecies differences (allometric scaling):

1

Justification:

allometric scaling is not applied for derivation of inhalation DNEL

AF for other interspecies differences:

2.5

Justification:

no other substance-specific effects are available

AF for intraspecies differences:

10

Justification:

default factor for general population

AF for the quality of the whole database:

1

Justification:

not required, available data fulfill scientific principles

AF for remaining uncertainties:

1

Justification:

not required, no other uncertainties need to be considered

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.67 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

600

Modified dose descriptor starting point:

NOAEL

Value:

1 000 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

oral to dermal, equivalent absorption assumed and therefore no correction applied

AF for dose response relationship:

1

Justification:

NOAEL is used as starting point

AF for differences in duration of exposure:

6

Justification:

based on the subacute study

AF for interspecies differences (allometric scaling):

4

Justification:

rats were used

AF for other interspecies differences:

2.5

Justification:

no other substance-specific data are available

AF for intraspecies differences:

10

Justification:

default factor for general population

AF for the quality of the whole database:

1

Justification:

available data fulfill the scientific requirements

AF for remaining uncertainties:

1

Justification:

no other uncertainties need to be considered

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.67 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

600

Modified dose descriptor starting point:

NOAEL

Value:

1 000 mg/kg bw/day

AF for dose response relationship:

1

Justification:

NOAEL is used as the starting point

AF for differences in duration of exposure:

6

Justification:

based on the sub-acute study

AF for interspecies differences (allometric scaling):

4

Justification:

rats were used

AF for other interspecies differences:

2.5

Justification:

no other substance-specific effects are available

AF for intraspecies differences:

10

Justification:

default factor for general population

AF for the quality of the whole database:

1

Justification:

available data fulfill the scientific requirements

AF for remaining uncertainties:

1

Justification:

no other uncertainties need to be considered

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - General Population

See description of relevant data in section on workers.